PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Breast Cancer Clinical Trial

Official title:

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084536
• Other study ID #: 201703053
• Status: Completed
• Phase: Phase 2
• Start date: June 7, 2017
• Est. completion date: February 25, 2021

Study information

• Verified date: March 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:
• unilateral axillary dissection
• unilateral modified radical mastectomy
• mastectomy with same day unilateral reconstruction
• unilateral sentinel lymph node biopsy (SLNB)
• partial mastectomy with unilateral SLNB
• simple mastectomy with unilateral SLNB
• At least 18 years of age.
• Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
• Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).

Exclusion Criteria:

• Planned for bilateral axillary or bilateral reconstruction surgery.
• Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy
• Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
• Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.
• Known contraindications to peripheral nerve block placement.
• Pregnant or breastfeeding.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition
• Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Cancer of Breast
• Mastodynia
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
-Given after general anesthesia
• Gabapentin
As per routine care Will not be prescribed for any patient with preexisting kidney disease or = 65 years.
• Celecoxib
As per routine care Will not be prescribed for any patient with preexisting kidney disease or = 65 years. Naproxen will be substituted for celecoxib in patients with sulfa allergies.
• Acetaminophen
-As per routine care
• Midazolam
-As per routine care
• Fentanyl
-As per routine care

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year	The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.; 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.	At 1 year
Primary	Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year	The participant is asked to rate their pain by circling the one number that best describes their pain on the average.; 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.	At 1 year
Primary	Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year	The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.; 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.; The scores for each subsection will be averaged.	At 1 year
Secondary	Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure	The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).; The higher the score the better quality of life.; Scores are standardized to a mean of 50 with a range of -0.809-70.71.	At baseline and 1 year post-surgery
Secondary	Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure	The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).; The higher the score the better quality of life.; Scores are standardized to a mean of 50 with a range of -1.465-77.09.	At baseline and 1 year post-surgery

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine